a study evaluating the efficacy and safety of biomarker-driven therapies in patients with persistent or recurrent rare epithelial ovarian tumors

Conditions: Ovarian Cancer

Summary: this study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.


Eligibility criteria:
inclusion criteria: * persistent or recurrent eoc that meets the following criteria: histologically confirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, including but not limited to low-grade serous ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, seromucinous carcinoma, malignant brenner tumors, grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma and small cell carcinoma of the ovary, hypercalcemic type (sccoht). disease that is not amenable to curative surgery * measurable disease (at least one target lesion) according to recist v1.1 * previous treatment with one to four lines of therapy, at least one of which was platinum-based. hormonal therapy does not count as a line of therapy. * platinum-resistant disease, defined as disease progression during or within 6 months of last platinum therapy, with the following exception: participants with primary platinum-refractory disease are excluded. * submission of a representative tumor specimen that is suitable for next-generation sequencing (ngs) testing and estrogen receptor immunohistochemistry (er ihc) to determine treatment arm assignment and for central pathology review. * submission of the local pathology report and, if available, any associated stained slides that supported the local diagnosis of the histology (to be used for central pathology review) * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic and end-organ function * for women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs (if applicable) * in addition to the general inclusion criteria above, participants must meet all of the arm-specific inclusion criteria for the respective arm general exclusion criteria: * pregnant or breastfeeding, or intending to become pregnant or breastfeed during the study * primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment * histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer * current diagnosis of solely borderline epithelial ovarian tumor * current diagnosis of non-epithelial ovarian tumors * current diagnosis of synchronous primary endometrial cancer * prior history of primary endometrial cancer, with the following exception: a prior diagnosis of primary endometrial cancer is permitted if it meets all of the following conditions: stage ia, no lymphovascular invasion, international federation of gynecology and obstetrics grade 1 or 2, not a high-grade subtype. * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * symptomatic, untreated, or actively progressing cns metastases * severe infection within 4 weeks prior to initiation of study treatment * treatment with chemotherapy, radiotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or investigational therapy within 28 days prior to initiation of study treatment * treatment with hormonal therapy within 14 days prior to initiation of study treatment * in addition to the general exclusion criteria above, participants can not meet any of the arm-specific exclusion criteria for the respective arm